Radiation plus docetaxel and cisplatin in locally advanced pancreatic carcinoma: A non-comparative randomized phase II trial

Autor: Frédéric Viret, Carmen Llacer, Marc Giovannini, Antoine Adenis, Thierry Conroy, Valérie Boige, Didier Peiffert, Michel Ducreux, Moncef Abbas, Beata Juzyna, Charlotte Baey, Jean-Pierre Pignon, Françoise Mornex, Patrice Cellier, Jaafar Bennouna
Přispěvatelé: Institut Gustave Roussy (IGR), Université Paris-Sud - Paris 11 - Faculté de médecine (UP11 UFR Médecine), Université Paris-Sud - Paris 11 (UP11), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), CRLCC Val d'Aurelle - Paul Lamarque, CRLCC René Gauducheau, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Department of Radiation Oncology, Centre Hospitalier Universitaire Lyon Sud, Pierre Benite, France, Hospices Civils de Lyon (HCL), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), Université Paris-Sud 11 - Faculté de médecine (UP11 UFR Médecine), Centre Oscar Lambret [Lille], Institut de Cancérologie de Lorraine - Alexis Vautrin (ICL), Institut de cancérologie de l'Ouest - Paul Papin (ICO - Paul Papin), Université Lille Nord de France (COMUE)-UNICANCER
Rok vydání: 2014
Předmět:
Male
Oncology
medicine.medical_treatment
MESH: Taxoids
Phases of clinical research
Docetaxel
Gastroenterology
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
Clinical endpoint
030212 general & internal medicine
MESH: Chemoradiotherapy
MESH: Treatment Outcome
MESH: Aged
MESH: Middle Aged
Chemoradiotherapy
Middle Aged
3. Good health
MESH: Antineoplastic Combined Chemotherapy Protocols
Treatment Outcome
MESH: Young Adult
MESH: Survival Analysis
030220 oncology & carcinogenesis
Female
Taxoids
Fluorouracil
MESH: Pancreatic Neoplasms
medicine.drug
Adult
medicine.medical_specialty
Adolescent
Antineoplastic Agents
Radio-chemotherapy
MESH: Drug Administration Schedule
Drug Administration Schedule
Young Adult
03 medical and health sciences
Internal medicine
medicine
Humans
Aged
MESH: Adolescent
Cisplatin
MESH: Humans
Hepatology
business.industry
MESH: Adult
Survival Analysis
MESH: Male
Confidence interval
Pancreatic Neoplasms
Radiation therapy
Regimen
MESH: Cisplatin
MESH: Antineoplastic Agents
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
Pancreatic carcinoma
business
MESH: Female
MESH: Fluorouracil
Zdroj: Digestive and Liver Disease
Digestive and Liver Disease, 2014, 46 (10), pp.950-955. ⟨10.1016/j.dld.2014.06.006⟩
Digestive and Liver Disease, WB Saunders, 2014, 46 (10), pp.950-955. ⟨10.1016/j.dld.2014.06.006⟩
ISSN: 1590-8658
DOI: 10.1016/j.dld.2014.06.006
Popis: Background We performed a randomized, non-comparative phase II study evaluating docetaxel in combination with either daily continuous (protracted IV) 5-fluorouracil or cisplatin administered weekly, concurrent to radiotherapy in the treatment of locally advanced pancreatic carcinoma. Results of the docetaxel plus cisplatin regimen are reported. Methods Forty chemotherapy-naive patients with locally advanced pancreatic carcinoma were randomly assigned to receive 5-fluorouracil and docetaxel or docetaxel 20 mg/m2 and cisplatin 20 mg/m2/week, plus concurrent radiotherapy for 6 weeks. The radiation dose to the primary tumour was 54 Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate. Results 51 patients from 7 centres were included in the docetaxel–cisplatin treatment group. Six-month non-progression rate was 39% (95% confidence interval: 26–53). Median overall survival was 9.6 months (95% confidence interval: 2.4–60.7); 6 complete and 8 partial responses were obtained. Six patients survived more than 2 years after their inclusion in the trial. Grade ≥3 toxicity was reported in 63% of patients; no treatment-related death occurred. Severe toxicities were mainly anorexia (22%), vomiting (20%) and fatigue (24%). Conclusions Despite inadequate efficacy according to the main end point, this regimen gave a satisfactory rate of objective response (27%) with tolerable toxicity.
Databáze: OpenAIRE
Externí odkaz: